Quality Assurance Consultant
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.
They are a company that develops and manufactures Devices used to assess/evaluate the body and circulation. Due to the fall out of an employee they are looking for a consultant to support the current workload.
ROLE DESCRIPTION
As the new consultant you will focus your tasks on the deadlines for the new ISO 13485 certification and the CE mark. You will work with the team on the devices and ensure that the quality systems are conform the regulations. The systems have to be improved, implemented and maintained what your responsibility will be. The project is estimated to be for at least 6 months with extension possible for another 6 months.
RESPONSIBILITIES
• Besides focusing on the new implementation of ISO 13485 your other responsibilities will be:
• Complaint handling
• You will set up CAPA's
• You will be in contact as single point of contact with other agencies and bodies such from outside Europe
• Improve quality awareness in the company
REQUIREMENTS
• At least a Bachelor Degree
• 3-5 years experience in Medical Devices or other highly regulated environments
• Knowledge of ISO 13485
• Audit experience is a plus
• Fluent in English speaking and writing
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
